MAUDE Adverse Event Report: DRIVE MEDICAL KNEE SCOOTER

Model Number	790
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report an adverse event and product issues with her drive knee scooter.Patient stated that she was using this scooter after having ankle surgery, and it was rented from a medical supply store.Patient stated that the front wheels are 18 inches apart, while the back wheels are 8 inches apart and that this creates instability when using the scooter.Patient said when mounting the scooter from the side, if the handle bars are tilted, you fall right over.Patient said she fell hard on her ankle that had surgery and it caused her such severe pain, she almost passed out.Patient said she feels the device may need to be recalled due to poor design and danger of tipping over.

• Brand Name: KNEE SCOOTER
• Common Device Name: KNEE SCOOTER
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 7380857
• Report Number: MW5076202
• Device Sequence Number: 19119354
• Product Code: ITJ
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 790
• Device Catalogue Number: HX59JP
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR